OVERVIEW
A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-Oncology Plasma Cell-Related Diseases
PROTOCOL SUMMARY
The goal of this clinical study is to learn more about the study drug Anitocabtagene autoleucel (anito-cel), and its safety, tolerability, dosing, and preliminary effectiveness in participants with generalized myasthenia gravis (GMG). Anito-cel is a B-cell maturation antigen (BCMA)-directed CAR-T cell therapy. The primary objective of this study is to assess the safety profile, including any dose-limiting toxicity (DLT) and identification of a maximum tolerated dose (MTD) (if applicable), to support selection of the recommended Phase 2 dose (RP2D) of anito-cel when administered to participants with GMG.
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Muscular Diseases, Neuromuscular Manifestations, Autoimmune, Autoimmune Diseases, Autoimmune Diseases of the Nervous System, Myasthenia Gravis, Muscle Weakness
Gender
N/A
Date
April 2025 - October 2028
Study Type
Interventional
Study Phase
Phase 1
Product
anito-cel, Cyclophosphamide, Fludarabine
Eligibility information
Inclusion criteria
- Individuals must be 18 years of age or older
- Must have Myasthenia Gravis Foundation of America (MGFA) clinical classification Grades 2-4A at time of screening
- Participant must have clinically active disease and requiring ongoing therapy for Generalized Myasthenia Gravis (GMG)
- MG-ADL score ≥ 6 and QMG score ≥ 10 at screening
- GMG specific autoantibodies must be above the reference laboratory upper limit of normal (ULN)
Exclusion criteria
- Individual is pregnant or breastfeeding
- Treatment with Anti-CD20 agents, calcineurin inhibitors, FcRN inhibitors, azathioprine, mycophenolate mofetil, methotrexate, or cyclophosphamide within the specified time frame prior to leukapheresis or prior to anito-cel infusion
- Previous treatment with any gene therapy, chimeric antigen receptor therapy or T cell engager
- Previous thymectomy within 6 months of screening
- Major chronic illness that is not well managed at the time of study entry and in the opinion of the investigator
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
Locations (14)
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
UC Irvine Medical Center
Orange, California, United States, 92868
Stanford Blood and Marrow Transplant
Palo Alto, California, United States, 94305
University of South Florida - Carol and Frank Morsani Center for Advanced Healthcare
Tampa, Florida, United States, 33612
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
University of Minnesota Delaware Clinical Research Unit
Minneapolis, Minnesota, United States, 55455
Columbia University Irving Medical Center
New York, New York, United States, 10032
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Oregon Health & Science University
Portland, Oregon, United States, 97239
Lewis Katz School of Medicine at Temple University
Philadelphia, Pennsylvania, United States, 19140
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
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